MAUDE Adverse Event Report: ST JUDEMEDICAL, NEUROMODULATION PROTEGE; SCS IPG

Model Number 3789

Device Problem Unintended Movement (3026)

Patient Problem Pain (1994)

Event Date 08/27/2014

Event Type  Injury  

Event Description

The pt reported he experienced pain at the ipg site after overextending himself and it felt as though the ipg moved in the pocket.Surgical intervention was undertaken on (b)(6) 2014 and the pt's ipg was relocated.The pt is no longer experiencing pain at the ipg site.

Manufacturer Narrative

Sjm has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.Sjm defers to the patient's physician regarding medical history.

• Brand Name: PROTEGE
• Type of Device: SCS IPG
• Manufacturer (Section D): ST JUDEMEDICAL, NEUROMODULATION; plano TX
• Manufacturer Contact: toi milner ; 6901 preston rd.; plano, TX 75024 ; 9723098107
• MDR Report Key: 4308631
• MDR Text Key: 5132048
• Report Number: 1627487-2014-15854
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Type of Report: Initial
• Report Date: 11/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2016
• Device Model Number: 3789
• Device Lot Number: 4510065
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/10/2014
• Initial Date FDA Received: 12/01/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: IMPLANT:; SCS LEAD: MODEL 3186 (2); IMPLANT:; SCS ANCHOR: MODEL 1192 (2)
• Patient Outcome(s): Other
• Patient Age: 62 YR